Office of the Institutional Review Board
IRB Meeting

Guidance

Note: Posted Guidance documents on this website do not represent an all inclusive list. Please call the Office of the IRB at 210-567-8250 with any questions concerning current guidance.

Instructions:

Always return to this webpage to ensure you are using the most current Guidance.

Advertising - Guidelines for Advertising for Research Subjects

Related Policy: Identification and Recruitment of Participants
pdf for PC

Assurance Letter

A letter containing the UTHSCSA FWA number, numbers of the IRBs listed under this FWA and a list of affiliated institutions covered by the IRB under general IRB Authorization Agreements.

pdf for PC
CITI Instructions (Sign-up and affiliate)   pdf for PC
CITI Instructions (Navigate to courses)   pdf for PC

CITI Learner Groups - Instructions on changing CITI Learner Group

  pdf for PC
Community Participatory Research Guidance  
pdf for PC

Consenting Process - Guidance on Observation of the Consenting Process

Related Policy: Informed Consent

Related SOP: Obtaining Informed Consent

pdf for PC
DoD Research See the Policy: DoD Research Policy and Procedure

Existing Specimens -Guidelines for IRB Applications Involving the Use of Existing Specimens

 
pdf for PC

Gender Differences - FDA Guidance on Study of Gender Differences in the Clinical Evaluation of Drugs

 
pdf for PC
Informed Consent See the SOP: Obtaining Informed Consent  
LAR - Guidance related to legally effective informed consent under HHS, FDA, VA regulations and Texas state law “Legally Authorized Representatives Under Federal and Texas Law”
pdf for PC

IRB Guidance on Data and Safety Monitoring Plan

 
pdf for PC
IRB of Record - Guidance on Serving as IRB of Record   pdf for PC
Planned Emergency - Guidance on Planned Emergency Research, Exception from Informed Consent, and Waiver of Applicability of Informed Consent   pdf for PC

Pregnancy Exposure Registry -
FDA Guidance for Industry: Establishing Pregnancy Exposure Registries

  FDA Guidance
Recruitment - Guidance on UT Medicine Patient Recruitment Related Policy: Identification and Recruitment of Participants
pdf for PC

Waivers and Alterations Guidance

Related Policy: Informed Consent
pdf for PC